In the field of diagnostics, it is necessary in many cases to obtain samples of body fluid, more particularly blood samples or samples of interstitial fluid, so that one or more analytes therein can be detected, especially in a specific manner. Examples of such analytes, which can also be detected in the context of the present disclosure, are glucose, more particularly blood glucose, coagulation parameters, triglycerides, lactate, cholesterol or combinations of the aforementioned analytes and/or other metabolites. Depending on the concentrations detected, it is then possible, for example, to make a decision about the appropriate treatment.
For the purpose of analyte detection, one or more analytical aids are generally used in order to obtain and/or to analyze the samples. Thus, the analytical aids can comprise, for example, one or more lancets, i.e. elements which are designed to generate in a user's skin an opening through which the body fluid can be withdrawn. With regard to examples of such lancets, reference can be made to WO 01/36010 A1. Alternatively or in addition, the analytical aids can comprise one or more test elements comprising one or more test chemistries which can be designed to change certain detectable properties upon exposure to the analyte to be detected. For example, analyte detection can comprise detection of electrochemical properties of the analytes themselves and/or of other substances, and/or a change in electrochemically detectable properties. Alternatively or in addition, it is also possible, for example, to detect optical properties and/or changes therein. For a description of possible test chemistries, reference can be made to, for example, J. Hones et al.: Diabetes Technology and Therapeutics, vol. 10, Supplement 1, 2008, S-10 to S-26. In addition, reference can be made to, for example, WO 2010/094426 A1 or WO 2010/094427 A1. These documents also describe analytical aids comprising a test chemistry which is also usable in principle in the context of the present disclosure.
EP 1 543 934 A2 discloses an injection-molded plastics part having an embedded component, and a corresponding production process. This document describes, for example, the production of what are known as analytical chips which are overmolded with a plastic frame. At least one process in which a glass body is surrounded by a plastic frame is described herein. More particularly, the process is suitable for the production of what are known as biochips. In the case of these biochips, the untreated surfaces of the glass support are coated at a later stage, i.e. after the connection of the plastic frame to the glass support, with appropriate reagents required for usage of biochips.
In addition, integrated analytical aids are known which are used not only for the purpose of generating the sample of body fluid, but also for the purpose of transportation of the sample and, optionally, even for the purpose of qualitative and/or quantitative analysis of said sample. Examples of such analytical aids are aids containing what are known as microsamplers, in which a lancet is used to make a prick or a cut and in which the sample is accommodated and is transported to one or more test fields comprising the test chemistry. These test fields can be arranged separately from the lancet, but can also be a component of the lancet itself. Such systems, which are described in, for example, US 2004/0193202 A1, US 2008/0249435 A1, WO 03/009759 A1, WO 2010/094427 A1 or WO 2010/094426 A1, are especially user-friendly owing to their high degree of integration.
EP 2 226 007 A1 describes an analytical magazine comprising chambers in which analytical aids are stored. The analytical aid comprises at least one test element for the detection of at least one analyte in a sample of a body fluid. The test element comprises a test field, with the test field being at least partly arranged within the respective chamber and with a wall of the chamber at least partly covering the test field and at least partly delimiting a test field area accessible from the chamber. For example, the test field may also be connected to the housing in a time-independent and/or process-independent manner with respect to the connection of a membrane to the housing. The test fields can be applied at a later time, and so half-finished elements can be temporarily stored without test fields.
US 2005/0283094 A1 describes a test device for testing a body fluid, the test device comprising a test strip, a piercing element and a housing. As described herein, for example, the test strip and the housing can also be in the form of a single body, and so the housing or a part thereof also functions as a test strip. For example, a shaping process can be used to produce said single-body test element housing.
Analytical aids are generally provided or produced in the form of magazines in which a plurality of such analytical aids is accommodated. For example, these analytical aids, which are generally in the form of disposables, are inserted into a one-piece or multi-part magazine body during production. However, this insertion procedure is in practice comparatively complex, since generally very small structures have to be fitted with very small disposables. Particularly in the case of analytical aids in the form of test elements which are firmly integrated into a magazine, this procedure is complex since partial adhesiveness of the magazine has to be produced first, for example by printing adhesive in a targeted manner or by inserting a piece of double-sided adhesive tape. Only thereafter is it generally possible to mount an actual test field comprising the test chemistry.
It is therefore an object of the present disclosure to provide an analytical aid and a process for producing an analytical aid which at least substantially avoid the disadvantages of known analytical aids and processes. More particularly, the process shall be realizable in a cost-effective manner and implementable on an industrial scale, and more particularly the complexity of integrating the test chemistry into the analytical aid shall be reduced compared to known production processes.